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临床试验/NCT03696043
NCT03696043终止不适用

Application of Image Guidance Technology to Bedside External Ventricular Drain Placement

University of Wisconsin, Madison1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2018年8月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
31
试验地点
1
主要终点
Number of catheter passes or attempts

研究概览

简要总结

External ventricular drain (EVD) placement is performed very often in neurosurgical practices. EVD's are most commonly placed at the bedside using external anatomical landmarks to guide the catheter into the frontal horn of the ipsilateral lateral ventricle. EVDs are often placed due to acute neurological compromise and require timely insertion.

Accurate catheter placement is essential to achieving effective external CSF drainage without complications or occlusion/failure of the catheter. Catheter placement is most commonly performed via a freehand approach using external anatomical landmarks to help identify the location of the lateral ventricle within the brain without the aid of imaging. Proper identification of the ventricles on pre-procedure imaging, surgeon skill, and estimation of pathologic perturbations to the normal location of the ventricles all factor into the success of catheter placement. Multiple passes are often required. The accuracy rate from the freehand technique has been reported to range from 40 to 98 percent.

Current methods for EVD placement do not compensate for superficial brain vessels or pathology that may alter the intracranial anatomy such as trauma, hemorrhage, or mass lesions. Some studies have attempted to use CTA imaging to identify intracranial vessels in an attempt to avoid them during placement.

Image guidance is a tool used very commonly for placement of EVD's and shunts in the operating room. AxiEM Stealth is a noninvasive image localization modality that registers a CT or MRI to the individual patients facial and scalp anatomy.

This study will compare the current standard of care of freehand placement of bedside external ventricular catheters to the placement of EVD catheters with AxiEM Stealth image guidance.

详细描述

External ventricular drain (EVD) placement is performed very often in neurosurgical practices. EVD's are used most commonly to monitor intracranial pressure and divert cerebrospinal fluid (CSF) in patients with increased intracranial pressures. Pathologies where EVDs are most frequently needed include hydrocephalus, malignancy, and/or trauma. EVD's are most commonly placed at the bedside using external anatomical landmarks to guide the catheter into the frontal horn of the ipsilateral lateral ventricle. EVDs are often placed due to acute neurological compromise and require timely insertion. This can increase the associated risk and result in complications.

Accurate catheter placement is essential to achieving effective external CSF drainage without complications or occlusion/failure of the catheter. Catheter placement is most commonly performed via a freehand approach using external anatomical landmarks to help identify the location of the lateral ventricle within the brain without the aid of imaging. Proper identification of the ventricles on pre-procedure imaging, surgeon skill, and estimation of pathologic perturbations to the normal location of the ventricles all factor into the success of catheter placement. Multiple passes are often required. The accuracy rate from the freehand technique has been reported to range from 40 to 98 percent. A very basic grading scale has been developed to assess placement but does not include items such as the number of passes until successful placement and presence of post placement hemorrhage or other neurological complications. An increased number of passes increases the risk of post placement hemorrhage and may damage the brain. Hemorrhage has been reported to occur after catheter placement at rates ranging from 0.2 to 41 percent.

Current methods for EVD placement do not compensate for superficial brain vessels or pathology that may alter the intracranial anatomy such as trauma, hemorrhage, or mass lesions. Some studies have attempted to use CTA imaging to identify intracranial vessels in an attempt to avoid them during placement.

Image guidance is a tool used very commonly for placement of EVD's and shunts in the operating room. AxiEM Stealth is a noninvasive image localization modality that registers a CT or MRI to the individual patients facial and scalp anatomy. A probe can then be used to identify, in real-time, the underlying anatomy and trajectories. This imaging guidance may improve the accuracy of EVD placement.

This study will compare the current standard of care of freehand placement of bedside external ventricular catheters to the placement of EVD catheters with AxiEM Stealth image guidance. Accuracy of the tip of the catheter, occurrence of post-placement hemorrhage, the number of passes required for CSF flow, ventricle diameter, catheter clogging/failure, time required for placement, patient demographics and other secondary outcome measures such as Glasgow Outcome Scale (GOS) and Modified Rankin Score (MRS) will be collected. The hypothesis is that image guided EVD catheter placement will improve accuracy, decrease the number of brain transgressions, and decrease complications of EVD placement.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

Target of 100 participants - 50% freehand EVD placement and 50% image guided EVD placement. Randomization is every other patient will received image guided EVD placement

入排标准

年龄范围
18 Years 至 88 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing bedside external ventricular drain placement determined by attending physician
  • Age ≥ 18 years and ≤ 88 years
  • Male or Female
  • Patients or consentable family member must sign a written informed consent prior to EVD placement
  • Stealth compatible head CT or MRI

排除标准

  • Patients ≤ 18 and ≥ 88 years of age
  • Prisoner status
  • Subjects who decline participation into the study
  • Subjects determined to be medically or neurologically to high of a risk for the study, determined by attending physician
  • Patients who undergo emergent EVD placement via emergency consent
  • Subjects for whom self-consent or consent by a LAR cannot be obtained or cannot be obtained
  • Pregnant women
  • Non-English speaking patients

研究组 & 干预措施

EVD placement

Active Comparator

Catheter placement is most commonly performed via a freehand approach using external anatomical landmarks to help identify the location of the lateral ventricle within the brain without the aid of imaging. Proper identification of the ventricles on pre-procedure imaging, surgeon skill, and estimation of pathologic perturbations to the normal location of the ventricles all factor into the success of catheter placement. Multiple passes are often required. The accuracy rate from the freehand technique has been reported to range from 40 to 98 percent.

干预措施: EVD placement (Other)

Axium Stealth Image Guidance

Experimental

The novelty of this study is to investigate whether using image guidance technology can improve EVD catheter placement. Image guidance is used very commonly for EVD and shunt placement in the operating room with excellent accuracy and precision. We hypothesize that using this same workflow at the bedside will improve accuracy; decrease the number of passes needed for a successful placement, decrease the number of post-placement hemorrhagic events, and help improve the effectiveness of the catheter as well as patient outcomes.

干预措施: Axium Steatlh Image Guidance (Other)

Axium Stealth Image Guidance

Experimental

The novelty of this study is to investigate whether using image guidance technology can improve EVD catheter placement. Image guidance is used very commonly for EVD and shunt placement in the operating room with excellent accuracy and precision. We hypothesize that using this same workflow at the bedside will improve accuracy; decrease the number of passes needed for a successful placement, decrease the number of post-placement hemorrhagic events, and help improve the effectiveness of the catheter as well as patient outcomes.

干预措施: EVD placement (Other)

结局指标

主要结局

Number of catheter passes or attempts

时间窗: baseline

Collection of number of passes needed for successful catheter placement

Accuracy of catheter tip compared to foramen of Monro

时间窗: baseline

Measurement of accuracy for catheter tip compared to foramen of Monro with accuracy formula

次要结局

  • New neurological deficits(baseline and 12 months)
  • Durability of EVD(baseline and 12 months)
  • Infection rate(baseline and 12 months)
  • Occurrence of post-placement hemorrhage(baseline and 12 months)
  • Time required catheter insertion(baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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